FDA Quietly Sunsetting Summary Reporting Program For Adverse Events, Readies Public Release Of Millions Of Pre-2017 Summarized MDR Reports

The US FDA expects to turn the lights out on its 22-year-old Alternative Summary Reporting Program for adverse events at the end of May, the agency tells Medtech Insight. But it's the FDA's upcoming online release of millions of summarized Medical Device Reports sent to the agency between 1998 and 2017 that could have the tongues of industry – and the public – wagging.